Can an App Supporting Psoriasis Patients Improve Adherence to Topical Treatment? A Single-blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Odense University Hospital
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Percentage of Adherent Participants
Study Overview
Brief Summary
Medical adherence to topical corticosteroid products in psoriasis patients is a main determinant for poor treatment effect.
The investigators aim to test if a multifaceted intervention delivered in an app (MyPso QualityCareTM owned by Leo Pharma) for smartphones combined with an Electronic Monitor (EM) (Teslo) can improve medical adherence among psoriasis patients treated with a topical calcipotriol/betamethasone dipropionate foam combination (Cal/BD) (Enstilar©).
The study is classified as a phase 4 study, since it is studied if improved use of Enstilar© results in improved treatment outcomes.
Link to published study protocol:
https://bmcdermatol.biomedcentral.com/articles/10.1186/s12895-018-0071-3
Link to published results from the study:
Detailed Description
Material and methods Intervention: Participants in the intervention group download a patient supporting app (MyPso SmarTop™ Version 1.0, owned by Leo Pharma) which combined with an EM (SmarTop™ number 053776, owned by Leo Pharma) has three functions: 1) Measures use of medication through EM, 2) measures degree of psoriasis by patients tracking symptoms, and 3) supports the patient with treatment and refill reminders.
Study type: Single-blind block randomized controlled trial. Sampling: Patients are sampled from the dermatology out-patient clinic at Odense University Hospital.
Eligibility criteria: Psoriasis patients aged 18-75 years with mild-moderate psoriasis. It is mandatory that patients have a smartphone and basic skills for use of the smartphone.
Estimated sample size: To be able to improve medical adherence, the investigators wish to detect an 8 % difference between number of applications between intervention and control arm in use of Enstilar© over a 4 week treatment period. Confidence Interval (two-sided) using 95 % C.I., power 80, ratio of sample size 1, mean number of application in intervention Group 90 % of recommended daily application / 4 weeks, S.D. 15 %, drop-outs maximum 10 %:
Total sample size: 134 participants All participants will be seen by trial principal investigator at all of the study visits.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Psoriasis patients aged 18-75 years with mild-moderate psoriasis. It is mandatory that patients have a smartphone and basic skills for use of the smartphone.
Exclusion Criteria
- •aged under 18 and above 75 years, guttate psoriasis, severe degree of psoriasis, i.e. pustular and erythrodermic psoriasis, lack of smartphone and user skills for the smartphone
Arms & Interventions
App as intervention + Enstilar©
Patients prescribed Calcipotriene + Betamethasone Dipropionatecutaneous foam receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.
Intervention: Calcipotriene + Betamethasone Dipropionate (Drug)
App as intervention + Enstilar©
Patients prescribed Calcipotriene + Betamethasone Dipropionatecutaneous foam receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.
Intervention: App (Device)
Outcomes
Primary Outcomes
Percentage of Adherent Participants
Time Frame: Week 4
Rate of adherent patients, defined as dichotomized adherence rates obtained by number of days with applied medication with a selected cut-off of 80%, with adherence rates above 80% considered adherent
Secondary Outcomes
- Lattice-System Physician's Global Assessment (LS-PGA)(Week 4, 8 and 26)
- Dermatology Life Quality Index (DLQI)(Baseline, week 4, 8 and 26)
Investigators
Mathias Tiedemann Svendsen
MD, PhD
Odense University Hospital